MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC TDXFLX SYSTEM; AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER

Catalog Number 04A24-96

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Hazy smoke with a burning odor was observed from an infrequently used tdxflx during assay calibration with the access door open.A review of service history for the tdxflx, serial number (b)(4), did not identify any issues that may have contributed to the current complaint.A review for similar complaints against the tdxflx analyzer found no similar issues or trends identified.A review of the tdx/flx system operations manual gives adequate instructions for shut down of the analyzer and also advises keeping all access doors closed to prevent damage to the air heater and the photomultiplier tube while running.The ambassador configured the system 2 parameters to disallow assay runs with the access door open.Additionally, a review of the 2016 ul certification memo contains adequate information noting abbott diagnostic equipment and accessories are certified to the appropriate safety standards, and adequate protection is provided for the operator against spread of fire from the equipment.Based on this investigation no systemic deficiency or malfunction was identified for the tdxflx (list number 04a24-96), serial number (b)(4).

Event Description

The customer observed smoke coming from the sample carousel area on the tdxflx analyzer.The customer stated that the smoke dissipated quickly and a burning odor was present.The customer stated that the analyzer is not used frequently.No flames were observed and no injury was reported.

Manufacturer Narrative

The device evaluation was reassessed and concluded that a malfunction occurred, therefore the device was not performing as intended, and conclusions code was corrected from (b)(4).

• Brand Name: TDXFLX SYSTEM
• Type of Device: AUTOMATED FLUORESCENT IMMUNOASSAY ANALYZER
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 5588462
• MDR Text Key: 43447172
• Report Number: 1628664-2016-00101
• Device Sequence Number: 1
• Product Code: JJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K904226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04A24-96
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/1994
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1